Clearance Summary
BMR-16 CLINIC MUSCLE STIMULATOR received FDA 510(k) clearance under submission number K840148, sponsored by Bio-Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1984-01-30.
- Submission: K840148
- Applicant / Sponsor: Bio-Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.